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Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) for two special protocol assessments (SPA) for the Company’s pivotal Phase 3 program with NAV5001 as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor. NAV5001 is an investigational imaging agent used to visualize dopamine transporters (DAT) in the brain using single photon emission tomography (SPECT) imaging. The SPAs are written agreements between the Company, as the program’s sponsor, and FDA regarding the design, endpoints and statistical analysis for the two pivotal Phase 3 clinical trials to be used in support of a potential NAV5001 New Drug Application (NDA). The Company is actively preparing for the initiation of the pivotal Phase 3 trials later this year.
“Reaching an agreement on the SPAs indicates that FDA considers the design of the program and positive results from the Phase 3 trials will be appropriate for FDA consideration for regulatory approval of NAV5001 as an aid in the diagnosis of Parkinsonian syndromes,” said William J. Regan, Navidea Senior Vice President, Global Regulatory Strategy. “In achieving the SPA agreements on a first-cycle review, we are extremely pleased to have more certainty around FDA registration requirements.”
The international, open-label, pivotal NAV5001 Phase 3 program consists of two similar clinical trials that will run in parallel and enroll approximately 550 total subjects who exhibit early stage tremor. Each Phase 3 trial was the subject of a SPA with FDA. The primary endpoint of both studies is to evaluate the relative diagnostic efficacy of the NAV5001 SPECT images compared with the diagnosis made by neurologists and that established by a consensus panel of three movement disorder specialists as the ‘Standard of Truth’. In one study, each subject will undergo SPECT imaging with NAV5001 only. In the second study, subjects will undergo SPECT imaging with both NAV5001 and an alternative SPECT agent, ioflupane, in a cross-over comparison design.